CEL-SCI Reports Monthly Patient Enrollment in February for Its Phase
3 Head and Neck Cancer Trial

March 01, 2016 09:00 AM Eastern Daylight Time

VIENNA, Va.--(EON: Enhanced Online News)--CEL-SCI
Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company")
today announced that during the month of February it has enrolled 27
patients in its ongoing Phase 3 trial of its investigational
immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients
with advanced primary head and neck cancer. Total patient enrollment for
the trial is now 724 as of February 29, 2016 in the world’s largest
Phase 3 study in head and neck cancer.

“Through clinical centers in 24 countries, we continue to enroll
patients at an average rate of about one per day. With enrollment
numbers now over 700, we are nearing our full enrollment goal”

“Through clinical centers in 24 countries, we continue to enroll
patients at an average rate of about one per day. With enrollment
numbers now over 700, we are nearing our full enrollment goal,” stated
CEL-SCI CEO Geert Kersten.

The current study goal is to enroll 880 patients through approximately
100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary
squamous cell carcinoma of the head and neck. The objective of the study
is to demonstrate a statistically significant improvement in the overall
survival of enrolled patients who are treated with the Multikine
treatment regimen plus standard of care ("SOC") vs. subjects who are
treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational
immunotherapeutic agent that is being tested in an open-label,
randomized, controlled, global pivotal Phase 3 clinical trial as a
potential first-line treatment for advanced primary squamous cell
carcinoma of the head and neck. Multikine is designed to be a different
type of therapy in the fight against cancer: one that appears to have
the potential to work with the body's natural immune system in the fight
against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative
Research and Development Agreement ("CRADA") with the U.S. Naval Medical
Center, San Diego, and at University of California, San Francisco
(UCSF), as a potential treatment for peri-anal warts in HIV/HPV
co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist
and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and
the prevention of anal cancer, is the Principal Investigator at UCSF,
which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements
for up to $3 million each with Ergomed Clinical Research Limited to
further the development of Multikine for cervical dysplasia/neoplasia in
women who are co-infected with HIV and HPV and for peri-anal warts in
men and women who are co-infected with HIV and HPV.

About CEL-SCI Corporation

CEL-SCI's work is focused on finding the best way to activate the immune
system to fight cancer and infectious diseases. Its lead investigational
therapy, Multikine (Leukocyte Interleukin, Injection), is currently
being studied in a pivotal Phase 3 clinical trial as a potential
neoadjuvant treatment for patients with squamous cell carcinoma of the
head and neck. If the study endpoint, which is a 10% improvement in
overall survival of the subjects treated with the Multikine treatment
regimen plus the current standard of care (SOC) as compared to subjects
treated with the current SOC only, is satisfied, the study results will
be used to support applications that the Company plans to submit to
regulatory agencies in order to seek commercial marketing approvals for
Multikine in major markets around the world. Additional clinical
indications for Multikine that are being investigated include the
treatment of cervical dysplasia in HIV/HPV co-infected women, and the
treatment of peri-anal warts in HIV/HPV co-infected men and women. A
Phase 1 trial of the former indication has been completed at the
University of Maryland. The latter indication is now in a Phase 1 trial
in conjunction with the U.S. Naval Medical Center, San Diego, under a
CRADA and UCSF.

CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope
Antigen Presentation System) technology for the potential treatment of
pandemic influenza in hospitalized patients and as a potential vaccine
for the treatment of rheumatoid arthritis.

The Company has operations in Vienna, Virginia, and in/near Baltimore,
Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. When
used in this press release, the words "intends," "believes,"
"anticipated," "plans" and "expects," and similar expressions, are
intended to identify forward-looking statements. Such statements are
subject to risks and uncertainties that could cause actual results to
differ materially from those projected. Factors that could cause or
contribute to such differences include, an inability to duplicate the
clinical results demonstrated in clinical studies, timely development of
any potential products that can be shown to be safe and effective,
receiving necessary regulatory approvals, difficulties in manufacturing
any of the Company's potential products, inability to raise the
necessary capital and the risk factors set forth from time to time in
CEL-SCI Corporation's filings with the Securities and Exchange
Commission, including but not limited to its report on Form 10-K for the
year ended September 30, 2015. The Company undertakes no obligation to
publicly release the result of any revision to these forward-looking
statements which may be made to reflect the events or circumstances
after the date hereof or to reflect the occurrence of unanticipated
events.

*Multikine (Leukocyte Interleukin, Injection) is the trademark that
CEL-SCI has registered for this investigational therapy, and this
proprietary name is subject to FDA review in connection with the
Company's future anticipated regulatory submission for approval.
Multikine has not been licensed or approved for sale, barter or exchange
by the FDA or any other regulatory agency. Similarly, its safety or
efficacy have not been established for any use. Moreover, no definitive
conclusions can be drawn from the early-phase, clinical-trials data
involving the investigational therapy Multikine. Further research is
required, and early-phase clinical trial results must be confirmed in
the Phase 3 clinical trial of this investigational therapy that is
currently in progress.

Contacts

Recent Stories

VIENNA, Va.--(EON: Enhanced Online News)--CEL-SCI Corporation (NYSE American: CVM) announces that it is extending the expiration date of its Series DD and Series EE warrants to July 1, 2018 (close ... more »